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Fluoroquinolone medicine composition

A fluoroquinolone and composition technology, applied in the field of veterinary fluoroquinolone pharmaceutical compositions, can solve the problems of difficult preparation, inconvenience and difficulty in use, etc., and achieve the effects of simple and easy operation of the preparation method, increased therapeutic effect, and improved drug content

Active Publication Date: 2014-06-04
LUOYANG HUIZHONG ANIMAL MEDICINE
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been found in production practice that this method has problems such as high preparation difficulty, poor product stability and frost resistance when preparing high-concentration (i.e. 5%-10% (g / ml)) enrofloxacin injection: With the increase of enrofloxacin concentration, the amount of sodium hydroxide required to completely dissolve it in water also increases, and it is very difficult to control the pH value of the injection at 9.5-10.5; even if the pH value of the injection is increased to 11.5 , the product is also extremely unstable, and crystals will precipitate after 1-2 hours of refrigeration at 0°C, and the crystals cannot be redissolved when the temperature rises, which is extremely inconvenient to use in the cold winter conditions in the north
[0003] For ciprofloxacin lactate injection, the existing technology can prepare 10% content, but the 10% content also has problems such as difficult preparation, poor product stability and frost resistance: and further increase in concentration will cause stability problems such as crystallization, At the same time, using the existing technology to increase the content of ciprofloxacin and enrofloxacin injection to more than 15%, especially to about 30% and low irritation is a clinical demand

Method used

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Examples

Experimental program
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Embodiment approach

[0017] The enrofloxacin used in the present invention was purchased from Zhejiang Guobang Pharmaceutical Co., Ltd., with a content of 98.5%, and batch number 120222-1; the enrofloxacin hexahydrate was prepared by Luoyang Huizhong Veterinary Medicine Co., Ltd. according to CN101961335A Example 1, with a content of 75.0%, batch number 20120102; Ciprofloxacin was purchased from Zhejiang Guobang Pharmaceutical Co., Ltd., with a content of 96.7%, batch number 111020-21.

[0018] Examples 1-15 prepared according to the technical solution of the present invention are shown in Table 1:

[0019] Table 1

[0020]

[0021]

[0022]

[0023] Note: The content of enrofloxacin hexahydrate is calculated by enrofloxacin.

[0024] Preparation:

[0025] Add the prescribed amount of enrofloxacin (or enrofloxacin hexahydrate, ciprofloxacin), co-solvent, water and antioxidants to an appropriate amount of organic solvent according to the above prescriptions, stir until completely disso...

Embodiment 16

[0026] Embodiment 16 comparative example composition

[0027] According to the Chinese patent CN101810569A, Example 1 discloses a preparation method of enrofloxacin injection comprising the following steps:

[0028] (1) Add 20 grams of enrofloxacin into 60ml of aqueous sodium hydroxide solution with a concentration of 0.4mol / l, and stir until the enrofloxacin is completely dissolved;

[0029] (2) Continue to add sodium hydroxide aqueous solution with a concentration of 0.4mol / l to adjust the pH value to 12;

[0030] (3) Add 20ml of acidulant lactic acid. During the addition of acidulant, enrofloxacin will first crystallize. With the addition of acidulant, when the pH value reaches neutral, enrofloxacin will completely dissolve;

[0031] (4) Add 0.5g sodium thiosulfate antioxidant to the neutral solution;

[0032] (5) Continue to add 0.5g of EDTA chelating agent;

[0033] (6) After step (5) is completed, dilute to 100ml with purified water, and filter the dilute solution thr...

Embodiment 17、15

[0036] Embodiment 17, 15% enrofloxacin injection

[0037] Enrofloxacin injection, each 100ml injection consists of the following ingredients: 15.2g enrofloxacin, an appropriate amount of 4% (w / v) sodium hydroxide aqueous solution, add water to 100ml.

[0038] Preparation method: Weigh 15.2g of enrofloxacin, suspend it in 50ml of water, add dropwise an appropriate amount of 4% (w / v) sodium hydroxide aqueous solution while stirring, adjust the pH value to 10, and dilute the water to 100ml.

[0039] The 15% enrofloxacin injection prepared in this example was placed at room temperature for 3 hours, and crystals were precipitated.

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Abstract

The invention provides a fluoroquinolone medicine composition. Every 100ml of fluoroquinolone medicine composition comprises the following components by weight: 10-30g of fluoroquinolone, 0.1-20g of cosolvent, 0-60g of water and the balance of organic solvent, wherein the cosolvent is a pharmaceutically acceptable acid cosolvent. The fluoroquinolone medicine composition provided by the invention has the advantages that the content of the fluoroquinolone medicine is greatly increased and the treating effect of one-time administration is greatly improved; since the organic solvent is adopted as the main solvent, compared with the conventional enrofloxacin injection liquid, the irritation of intramuscular injection is reduced; the prepared fluoroquinolone medicine composition is stable in character, and has no crystal precipitation after long-time storage; a preparation method is simple, is easy to operate and is easy for industrial large-scale production.

Description

technical field [0001] The invention relates to a veterinary fluoroquinolone pharmaceutical composition. Background technique [0002] Fluoroquinolones have obvious after-drug effects on Gram-positive bacteria and Gram-negative bacteria, and it is concentration-dependent, that is, the higher the drug concentration, the longer the after-drug effect. With the increasing dosage of clinical use, the concentration of enrofloxacin injection has gradually developed from the initial 0.5% (g / ml) to the current 10% (g / ml). Because enrofloxacin has very little solubility in water and is easily soluble in sodium hydroxide solution, the prior art mainly adopts the method of adding co-solvent sodium hydroxide to increase the concentration of enrofloxacin in the preparation of enrofloxacin injection. Solubility in water, taking into account the stability of the product and the best conditions for enrofloxacin to produce bactericidal effect, control the pH value to 9.5-10.5 (Chinese Veteri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K9/08A61K47/10A61K47/08A61P31/04
Inventor 张许科刘兴金张晓会
Owner LUOYANG HUIZHONG ANIMAL MEDICINE
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